Muscle, tendon, and nerve changes after botulinum toxin injections for post-stroke spastic equinovarus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, non-randomized pilot with four visits spanning baseline, injection, early follow-up, and a later end-of-study visit timed to the known action of botulinum toxin. At each visit investigators will perform three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) on the medial gastrocnemius and tibialis anterior of both legs to measure muscle, tendon, and neural properties. The design captures pretreatment, peak effect, and later-stage changes to inform sample size calculations and refine measurement methods for a future observational study. The goal is to generate quantitative data that could help optimize injection timing, dosing, and longer-term management strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
* 2\. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
* 3\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
* 4\. Pes equinovarus due to spasticity
* 5\. Clinical need for BoNT injection at the lower leg
* 6\. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
* 7\. First-ever, unilateral stroke

Exclusion Criteria:

* Musculoskeletal or other neurological problems affecting the lower limb
* Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
* Cognitive problems that impede measurements
* Severe co-morbidities
* Irritated skin or open wounds where ultrasound will be placed
* Pregnancy
* Profound atrophy of the muscles in the target area(s) of injection
* Participation in an interventional Trial with an investigational medicinal product (IMP) or device
* The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.

Where it's running

• Uz Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Fabienne Schillebeeckx, MD — UZ Leuven campus Pellenberg, secretariaat fysische geneeskunde en revalidatie blok 5
• Study coordinator: Fabienne Schillebeeckx, MD, PI
• Email: fabienne.schillebeeckx@uzleuven.be
• Phone: 0032 - 16338714

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.